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1、生物新藥開發與市場永昕生物醫藥1生物新药开发与市场總經理總經理 黃一旭黃一旭 博士博士vv永昕生物醫藥股份有限公司總經理永昕生物醫藥股份有限公司總經理 ( (現任現任) )vv美國美國 CR Rockville CR Rockville 科技部主任科技部主任 vv美國美國 CR Rockville CR Rockville 資深主任資深主任 ( (製造部負責人製造部負責人) ) vv行政院行政院衛生署藥品查驗中心衛生署藥品查驗中心顧問顧問 vv成都中醫藥大學成都中醫藥大學新藥研究開發中心新藥研究開發中心顧問顧問 vv專長：專長：v藥廠經營/管理，藥品開發，業務推廣，製藥法規及市場分析vv學歷學
2、歷v台大獸醫學士,獸醫師1977v美國路易西安那州西北大,碩士1983v美國奧本大學,博士1987永昕生物醫藥2生物新药开发与市场生物製劑的種類Therapeutics Gene TherapyIn Vivo DiagnosticsTherapeutic VaccineBioDeviceTissue RepairXenotransplantationNatural Product永昕生物醫藥3生物新药开发与市场生物製劑的特性複雜高分子物質複雜高分子物質三度空間結構特性三度空間結構特性生物有效性或活性生物有效性或活性需特殊需特殊安全測試安全測試永昕生物醫藥4生物新药开发与市场Critical P
3、arameters for BiologicsSafety( (安全性）安全性）Potency（強度）（強度）Purity（純度）（純度）Consistency（持續性）（持續性）Efficacy（有效性）（有效性）永昕生物醫藥5生物新药开发与市场新藥開發、製造、測試及申請流程流程新藥開發新藥開發Drug DevelopmentDrug Development臨床前動物試驗臨床前動物試驗Pre-clinicalPre-clinicalDevelopmentDevelopment申請審核新藥物申請審核新藥物Investigational New DrugInvestigational New D
4、rugApplication (IND)Application (IND)三階段人體臨床試驗三階段人體臨床試驗Clinical DevelopmentClinical Development申請藥物許可申請藥物許可BLABLA上市上市Introduction/DistributionIntroduction/DistributionTo the MarketTo the Market永昕生物醫藥6生物新药开发与市场Phases and QualityPre-Clinical - Close to cGMPPhase I - cGMP w/ some changesPhase II - cGMP
5、 w/ changesPhase III - cGMP w/ No ChangesBLA - No More Product Development永昕生物醫藥7生物新药开发与市场Process Development - MissionTo develop production processes of appropriate scale - from pre-clinical exploration to commercialization永昕生物醫藥8生物新药开发与市场Process ValidationCell CultureFiltrationChromatographyViral
6、ClearanceAseptic Manipulation ValidationEquipmentOther - cleaning, storage,transferring, packaging, and shipping永昕生物醫藥9生物新药开发与市场Manufacturing SchemeHostHostBankBankProductionProductionPurificationPurificationModification/formulationModification/formulationPackagingPackaging永昕生物醫藥10生物新药开发与市场Manufactu
7、ring - OutlineMaster Cell Bank & Working Cell BankStarting Material ProductionPurificationModificationFormulationAseptic VialingLabeling永昕生物醫藥11生物新药开发与市场Clinical TrialsPre-Clinical & INDAnimal studies, safety, metabolic, pharmacological & process descriptionPhase I: Human SafetyClinical pharmacology
8、 studies永昕生物醫藥12生物新药开发与市场Clinical TrialsPhase II: EfficacyControlled studies in patients with disease or conditionBlinded clinical evaluation永昕生物醫藥13生物新药开发与市场Clinical TrialsPhase III: Safety and EfficacyBoth controlled and open trialsClosely monitored by sponsor for adverse reactions and information
9、 to be used for setting dosage requirements and labeling.永昕生物醫藥14生物新药开发与市场Clinical TrialsTreatment: (Physicians IND; Compassion)Involves patients with a serious, life threatening, or terminal illness when alternative treatment is not available or not effective and proposed treatment use has some evi
10、dence of effectiveness.永昕生物醫藥15生物新药开发与市场Documentation ControlTo reduce the risk of error due to oral or informal communication, to provide clear, written instructions, and to permit traceability.永昕生物醫藥16生物新药开发与市场DocumentTraining RecordSpecifications (supplies, chemicals, products)SOPsProduction Batc
11、h RecordsValidation Records + Equipment IQ/OQ/PQEquipment use log永昕生物醫藥17生物新药开发与市场CONTROLCONTROLAdocumentedprocessbywhichvalidatedproceduresareconsistentlyfollowedtoeliminatedunacceptabledeviationsfromtheestablishedstandards.永昕生物醫藥18生物新药开发与市场CONTROLGeneral ControlsDesign ControlFacility ControlEquip
12、ment ControlMaterial/Component ControlOperational ControlFinished Product Control永昕生物醫藥19生物新药开发与市场生物新藥市場評估需求評估需求評估New Case / YearTotal Case / Year用藥量市場占有率市場治療費用年永昕生物醫藥20生物新药开发与市场生物新藥市場評估 製作評估製作評估Patent /法律問題製造困難度（量產保存）體內外活性劑量（單一重複）藥品壽命永昕生物醫藥21生物新药开发与市场生物新藥市場評估Patent 費用製造費用臨床實驗費用臨床實驗結果取得時間永昕生物醫藥22生物新药开发与市场生物新藥市場評估Cost of GoodsPrice per doseCost per patient健保保險業給付健保保險業給付市場接受度市場接受度永昕生物醫藥23生物新药开发与市场生物新药开发与市场
